Temperature Monitoring With InnerSense Esophageal Temperature

Status Completed

Clinical Trial Summary

Very low birth weight (VLBW) infants (<1500 grams at birth) and other low birth weight infants experience hypothermia after birth and through stabilization (first 24 hours of life) due to an inability to keep warm through metabolic heat production while experiencing heat loss during care.

The investigator hypothesizes that inserting an InnerSense oral gastric tube (Philips Healthcare) with its imbedded thermistor and attaching the tube to a temperature monitor with a digital temperature display will enable care-providers to monitor continuous body temperature and prompt them to provide warmth and prevent heat loss, thus preventing hypothermia in these infants for the first 24 hours of life. The investigator predicts infants in the intervention group will have warmer axillary temperatures upon admission to the NICU and at 1, 4, and 8 hours of age. Mothers in non-active labor will be sought for consent to enroll their VLBW infant into this study after the infant's birth. 160 VLBW infants and other low birth weight infants 1000-2000 grams will be randomized to the intervention group (placement of InnerSense oral gastric tube with thermistor to a Squirrel monitor for continuous digital temperature display, immediately after birth through 24 hours of life) or the control group (standard delivery room care and stabilization care). The study staff plans to enroll 180 infants (90 per group) to allow for screen failures. Axillary temperatures of all infants will be recorded at NICU admission, 1, 4, 8 and 24 hours of age. Further, the study staff intends to enroll approximately 300 Intensive Care Nursery providers who care for an InnerSense study infant and wish to complete a provider satisfaction survey. These providers will be asked to provide consent prior to completing the survey and their names will be recorded on a separate study enrollment log.

Infant demographic data will be compared to make sure groups are not significantly different. Temperatures from the intervention group will be compared to the control group using a student t test at each time point. Satisfaction questionnaires will be summarized and described. The InnerSense oral gastric tube with temperature monitoring is FDA approved for use and is being marketed commercially by Philips Healthcare. VLBW infants have oral gastric tubes placed as standard of care for feeding, and intermittently in the delivery room when positive pressure ventilation is necessary for respiratory stabilization. There are no additional safety risks to the intervention of this study; however, a safety/data monitoring committee will be formed and meet quarterly to monitor the trial.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Body Temperature

Clinical Trial Details

NCT number	NCT02311972
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	N/A
Start date	November 2014
Completion date	June 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms